Neoplasms

Blood and Lymph Conditions

All Conditions

Hematologic Neoplasms

Hematologic Diseases

Dose Escalation: intravenous (IV) infusion of TQB2928 as monotherapy

4 weekly IV infusions (Days 1, 8, 15, and 22) of TQB2928 in each 28-day treatment cycle until unacceptable toxicity, documentation of confirmed progressive disease (PD), or subject withdrawal.

TQB2928 Injection

TQB2928 is a promising new molecular entity that mediates blockade of CD47 and SIRPα and enhances the phagocytosis of cancer cells by macrophages. In preclinical in vivo models, TQB2928 was active against a wide range of solid tumors and hematologic malignancies. This is the first-in-human phase 1 trial of TQB2928 in patients with advanced solid tumors and hematological malignancies.

Phase 1 Trial of the TQB2928 Injection in Patients With Advanced Cancers

A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TQB2928 Injection in Patients With Advanced Solid Tumors or Hematological Malignancies

DLTs will be assessed during the first 28 days of treatment for dose-escalation and are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle (28 days) of treatment.

MTD is defined as the highest dosing schedule cohort level at which no more than 1 of 6 patients experience a Dose Limiting Toxicity (DLT).

Maximum observed concentration (Cmax) of TQB2928 after administration

Minimum observed concentration (Cmin) of TQB2928 at steady state

The area under the curve (AUC) of serum concentration of TQB2928

Number of patients who develop detectable anti-drug antibody (ADA), and percentage of ADA positive patients will be calculated to evaluate immunogenicity of TQB2928.

Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by iRECIST v1.1 criteria for solid tumors, Lugano2014 criteria and lymphoma response to immunomodulatory therapy criteria (LYRIC) for lymphoma, and AML IWG 2003 response criteria for acute myeloid leukemia (AML).

Defined as the proportion of subjects with CR, PR, or SD.

Defined as the time from first documented response to documented disease progression.

Defined as the time from the first dose of TQB2928 to the first occurrence of disease progression or death from any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase 1 Trial of the TQB2928 Injection in Patients With Advanced Cancers	NCT04854681	Advanced Solid ...	TQB2928 Injecti...	18 Years -	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Phase 1 Trial of the TQB2928 Injection in Patients With Advanced Cancers	NCT04854681	Advanced Solid ...	TQB2928 Injecti...	18 Years -	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Spots Global Cancer Trial Database for advanced solid tumors and hematological malignancies